Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older

ABSTRACT

In most countries worldwide, pneumococcal conjugate vaccines have been included in the infant immunization program, resulting in a significant reduction in the burden of pneumococcal disease in children and adults. Shifting serotype distribution due to the indirect effect of infant vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) may continue to increase the gap between 23-valent pneumococcal polysaccharide vaccine (PPSV23) and PCV13 serotype coverage for older adults in the coming years. This clinical study (V110-029; NCT02225587) evaluated the safety and immunogenicity of sequential administration of PCV13 followed approximately 8 weeks later, or approximately 26 weeks later, by PPSV23 in healthy adults ≥50 years of age. Both dosing intervals were generally well tolerated as measured by the nature, frequency, and intensity of reported adverse events (AEs) in both vaccination groups. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 30 days following receipt of PPSV23 in either group and at Week 30 were generally comparable between the 2 groups for 6 serotypes unique to PPSV23 and 12 serotypes shared between PCV13 and PPSV23, regardless of the interval between receipt of PCV13 and PPSV23. In addition, administration of PPSV23 given either 8 weeks or 26 weeks following PCV13 did not negatively impact immune responses induced by PCV13. Furthermore, administration of PPSV23 given either 8 weeks or 26 weeks after PCV13 elicited serotype-specific OPA GMTs to serotypes unique to PPSV23, which could provide earlier protection against pneumococcal disease caused by these serotypes in comparison with the current Advisory Committee on Immunization Practices recommended interval of at least 12 months.

KEYWORDS:

• Pneumococcal vaccine
• safety
• immunogenicity
• sequential administration

Acknowledgments

Karyn Davis of Merck & Co., Inc., Kenilworth, NJ, USA assisted the authors with various administrative activities related to the submission of the manuscript and provided editorial assistance.

Disclosure of potential conflicts of interest

No author was paid for their work on this manuscript.

Conflicts of Interest

CP Andrews, J Ervin, and JT Peterson were investigators for the sponsor supported by research grants.

UK Buchwald, GM Tamms, D Krupa, P Ajiboye, L Roalfe, AL Krick, TM Sterling, M Wang, J Martin, JE Stek, MA Kohn, T Folaranmi, C Abeygunawardana, J Hartzel, and LK Musey are employees of the sponsors and may hold stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA.

Study identification: V110-029

CLINICALTRIALS.GOV identifier: NCT02225587

EudraCT #: 2013-003027-11

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website

Additional information

Funding

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (sponsor).

Notes on contributors

CP Andrews, J Ervin, and JT Peterson: enrollment of participants and/or data collection, review of the manuscript.

UK Buchwald, GM Tamms, D Krupa, P Ajiboye, L Roalfe, AL Krick, TM Sterling, M Wang, J Martin, JE Stek, MA Kohn, and T Folaranmi: analysis and interpretation of data, and preparation of manuscript.

C Abeygunawardana, J Hartzel, and LK Musey: study concept and design, analysis and interpretation of data, and preparation of the manuscript.